The present invention also refers to a sterile connection system between a sealed sterile vial closed by means of the above-mentioned plug and a tube for drawing said active substances for mixing them with a liquid diluent solution maintained in sterile conditions inside a container.
In hospital environments, there is often a need to administer to patients, by infusion or internal instillation, medical or nutritional active substances of various type, which are made available separately, in particular in powder or gel form, inside suitable sealed sterile vials.
In order to make the active substances suitable for liquid instillation or infusion, a mixture comprising, in addition to the active substance, a liquid diluent solution needs to be formed.
Such a liquid solution is usually made available in sterile conditions inside a flexible bag, from which, in addition to a mixture delivery tube, a drawing and mixing tube extends, provided with a terminal to be attached to the vial containing the active substance and to pierce the closing plug thereof.
However, the problem of ensuring sterility conditions even during and after the attachment of the active substance vial to the drawing and mixing tube extending from the liquid diluent solution bag still remains.
Any loss of sterility, in particular in the case of high-risk drugs, may lead to severe effects for both the patient and the healthcare personnel responsible for the patient care.
U.S. Pat. No. 5,699,923 A describes a hermetic closing plug for a sealed vial with internal sterile chamber for containing medical or nutritional active substances. The plug is suitable for the connection to a drawing and mixing tube which extends from a liquid diluent solution container and is provided with a terminal to be attached to the vial with a hollow tip for piercing the plug. The hollow tip is protected by a cap made of an axially compressible material capable of piercing an outer film or membrane for sealing the plug.